Recall Z-0055-2017 ยท DQO Catheter, Intravascular, Diagnostic
Vascular Solutions, Inc.
Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the
| Date | Oct 20, 2016 (initiated Sep 16, 2016) |
| Status | Terminated |
| Reason | Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. |
| Root cause | Process control |
| Action | Vascular Solutions sent an Urgent Medical Device Recall letter via first class mail beginning 9/16/2016. The letter identified affected product, stated the issue, and instructed that product should not be used and to be returned to Vascular Solutions. A response form was requested to be returned. Questions can be directed to Customer service by e-mail at customerservice@vasc.com. |
| Quantity | 11,670 units total |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico and outside the US to include: Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Saudi Arabia, South A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062877 | TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 Vascular Solutions, Inc., Jan 18, 2007 |